Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571864
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
AL Amyloidosis and Anti-CD38-Daratunumab
Sponsor:
None
Organization:
None
Study Overview
Official Title:
AL Amyloidosis and Anti-CD38-Daratunumab
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AL38
Brief Summary:
AL Amyloidosis and anti-CD38
Detailed Description:
AL amyloidosis is a systemic disorder characterized by progressive multiorgan failure and premature death While autologous stem cell transplantation ASCT is considered the standard therapy eligibility is limited and excludes a substantial proportion of patients Recent guidelines recommend daratumumab-based regimens for these patients but particularly for cases with severe renal involvement optimal treatment remains a challenge
This study explore the efficacy of daratumumab monotherapy in patients with histologically proven severe renal involvement who are ineligible for ASCT
This study explore the efficacy of daratumumab monotherapy in patients with histologically proven severe renal involvement who are ineligible for ASCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None